October 31, 1983
URGENT DRUG RECALL
RE: Konyne® Factor IX Complex (Human)
Koāte® Antihemophillic Factor (Human)
|Lot||Product Code||Lot||Product Code||Lot||Product Code|
|NC 8458||650-30||NC 8460||650-30||NC8461||650-30|
|NC 8462||650-70||NC 8470||650-30||NC 8474||650-30|
|NC 8475||650-20||NC 8476||650-20||NC 8477||650-50|
|NC 8479||650-30Z||NC 8480||650-30Z||NC 8489||650-30Z|
The purpose of this letter is to make you aware that the above lots contain plasma donated from an individual who subsequently was diagnosed as have Acquired Immune Deficiency Syndrome (A.I.D.S.).
Cutter is voluntarily withdrawing this material as a precautionary measure, as there is no evidence that these products will transmit the disease. No adverse reactions involving these lots have been reported.
Please examine your stock immediately to determine if you have any of the above lots on hand, and promptly return all units via UPS to the nearest Distribution Centers:Cutter Distribution Center
- 15320 East Salt Lake Avenue
City of Industry, CA 91744
ATTENTION: RECALL COORDINATORCutter Distribution Center
- 6155 Purdue Drive
Atlanta, GA 30336
ATTENTION: RECALL COORDINATOR
Please institute similar measure to assure that all recipients of the above material from you are notified and arrangements made for return of all units.
You will be credited for your returned goods and the postage. Would you please return the enclosed postcard immediately providing the requested information.
This recall is being made with the knowledge of the Food and Drug Administration. If you have any questions, please contact coordinator, Jean Huxsoll, at (415)420-5154. Thank you for your assistance.
John H. Cherry
Director, Group Quality Assurance